Toxicologic Clinical Pathology

One very important discipline in the preclinical data puzzle used to assess toxic treatment effects of new compounds and their potential adversity is clinical pathology. Clinical pathology, a specialized discipline in veterinary sciences focused on hematology, clinical chemistry, coagulation and bone marrow physiology is often underestimated in terms of the expert knowledge required to properly plan, implement and then interpret resulting laboratory data, either isolated (suboptimal) or within the context of clinical observations, histopathology findings and toxicokinetic results (recommended practice).

Therefore, in North America it has been standard practice to include certified experts in Veterinary Clinical Pathology in preclinical studies in the entire process of blood sampling, laboratory analysis and quality control, and most importantly the final interpretation of results, while in Europe seeking the input of such specialists has been increasing over the past few years with the recognition that such expert input allows to rule out overinterpretation or false interpretation of equivocal results, and make sense of potential incidental findings that may have an influence on the development success of new compounds.

Importantly, Pathology Experts has started to include expert clinical pathology reviews with an increasing number of clients, which has proven to provide significant value in the drug development process.